Director, QA Validation & Computer Systems Assurance

**Build our future together:**

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director of QA Validation to lead the QA Validation, Computer Systems Assurance (CSA), and Equipment Assurance functions for the Regeneron manufacturing site located in Saratoga Springs, NY. The director is responsible for qualification and validation strategy across a highly automated, digitally integrated biopharmaceutical facility, including process equipment, utilities, manufacturing execution systems (MES), laboratory information management systems (LIMS), distributed control systems (DCS), and enterprise platforms. The role applies risk-based methodologies aligned with FDA CSA guidance, GAMP 5 (2nd ed.), ICH Q9(R1)/Q10, and SDLC frameworks to maintain validated state across commercial and clinical manufacturing, and represents and defends the validation and CSA programs during FDA, EMA, and other regulatory inspe...